Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091633
Company: SUN PHARM INDS INC

• REMS

Products on ANDA 091633

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	2.5MG;200MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	10MG;200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091633

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2013	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/21/2024	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-16	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/09/2024	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/04/2021	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/22/2019	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/20/2018	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/14/2018	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A		Label is not available on this site.
09/14/2018	SUPPL-3	Labeling-Package Insert		Label is not available on this site.